Effect of Uterine Massage Versus Sustained Uterine Compression on Blood Loss After Vaginal Delivery

American University of Beirut Medical Center445 enrolled

Overview

The purpose of this study is to compare trans-abdominal uterine massage to sustained uterine compression after vaginal delivery with respect to blood loss and maternal pain. It is a randomized controlled trial that will be conducted at the American University of Beirut Medical Center - Delivery Suite.

Women allocated to either the massage or compression group will be given 10 units of oxytocin intramuscularly immediately after delivery of the shoulder and controlled cord traction will be performed to assist placental delivery. The umbilical cord will be clamped and cut approximately 1 minute after delivery of the baby. The uterine fundus will be rubbed and blood clots expelled as quickly as possible after delivery of the placenta.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

445

Conditions

Postpartum Hemorrhage

Interventions

Uterine MassagePROCEDURE

The massage will be performed as follows: palpating the uterine fundus, manually stimulating the fundus and the whole body of the uterus using fingers and palms steadily and repetitively.

Uterine CompressionPROCEDURE

The sustained uterine compression will be performed as follows: placing one hand in the vagina and pushing against the body of the uterus while the other hand compresses the fundus from above through the abdominal wall.

Eligibility

Sex: FEMALEMin age: 20 YearsMax age: 40 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Women giving birth vaginally, aged between 20 and 40 years, with a singleton pregnancy, gestational age of 36 or more weeks, and with fewer than or equal to three previous childbirths. Exclusion Criteria: * Exclusion criteria include multiple gestation, fetal malpresentation, the third stage of labor lasting more than 30 minutes, a previous cesarean delivery, chorioamnionitis, three or more previous induced abortions, preeclampsia, fetal death, polyhydramnios, hemoglobin of 9 g/L or less before delivery, coagulopathy, on magnesium sulfate infusion, abruptio placentae and having an abdominal wall too thick to palpate the fundus of the uterus or to perform uterine massage or compressions after delivery.

Locations (1)

American University of Beirut Medical Center

Beirut, Lebanon

Outcomes

Primary Outcomes

Incidence of blood loss of 500 mL or more

Collection of lost blood will be initiated immediately after delivery of the neonate by putting a drape under the woman's buttocks. Blood collected will be weighed on an electronic scale together with the drape, and the amount will be recorded in grams after subtracting the weight of the drape. The amount of blood loss will be recorded 30 mins after delivery of the neonate. The amount of lost blood in grams will be converted to volume by dividing by 1.06 (blood density in g/mL) for the analysis.

Time frame: 2 years

Secondary Outcomes

Maternal pain

Maternal discomfort and pain intensity will be evaluated after the intervention using a visual analogue scale (VAS), which consists of a two-sided rule with a 10 cm vertical or horizontal line linking two points, at one extreme indicating a total absence of pain and at the other the worst pain imaginable. The women will be required to mark a spot on the line corresponding to the intensity of their pain at that particular time on a possible scale of 0 to 10.

Time frame: 2 years

Change in hemoglobin as a measure of blood loss

The change in hemoglobin will be defined as the mean difference of pre-delivery hemoglobin versus post-delivery hemoglobin in each group.

Time frame: 2 years

Use of therapeutic uterotonics

the need to use uterotonic agent for PPH such a misoprostol or ergotamines

Time frame: 2 years

Use of balloon or surgical procedures for postpartum hemorrhage

needingto insert tamponading devices such as balloon

Time frame: 2 years

Need for blood transfusion and hospital stay

Data from ClinicalTrials.gov

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